MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN (NCT05495893) | Clinical Trial Compass
UnknownPhase 4
MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN
China224 participantsStarted 2022-07-25
Plain-language summary
A prospective, randomized, multicenter, open-label, parallel-arm Study to compare effectiveness of mycophenolate mofetil versus cyclophosphamide in the Induction Therapy of pediatric patients with Active Proliferative Lupus Nephritis in Chinese population
Who can participate
Age range5 Years – 17 Years
SexALL
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Inclusion criteria
✓. Age 5-17 years old;
✓. SLE patients who meet the updated 2019 eular/acr SLE classification criteria or 2012 SLICC diagnostic criteria;
✓. According to the revised International Society of Nephrology / Society of renal pathology (isn/rps) classification in 2018, it conforms to active proliferative ln type III or IV, with or without type V;
✓. No immunosuppressants such as cyclophosphamide, mycophenolate mofetil, cyclosporine A, tacrolimus, azathioprine, methotrexate, or biological agents such as rituximab, baileyoumab, and etaxel were used before enrollment.
Exclusion criteria
✕. A known history of primary immunodeficiency, splenectomy, or any potential disease that makes participants vulnerable to infection;
✕. Evidence of hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, or other serious infections;
✕. Have any history of tumor or cancer;
✕. Patients with lupus encephalopathy, diffuse alveolar hemorrhage, severe hemolytic anemia, blood routine platelet count lower than 10.0\*10\^9/l, glomerular filtration rate eGFR \< 60 ml/min/1.73 m2, or patients with other serious complications have unstable vital signs;
What they're measuring
1
Effective rate of LN treatment
Timeframe: 6 months
Trial details
NCT IDNCT05495893
SponsorSecond Xiangya Hospital of Central South University